Treatment of Severely Obese Children and Adolescents Employing "Family-based Behavioral Social Facilitation Treatment"

NCT ID: NCT02687516

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2021-05-31

Brief Summary

This study aims to evaluate the effectiveness of Family-based behavioral social facilitation therapy (FBSFT) in the treatment of severe obesity in children and adolescents compared to treatment as usual (TAU). The FBSFT condition includes 17 weekly family-based treatment sessions at the hospital obesity clinic followed by monthly follow-up sessions with their local nurse and follow-up sessions at the hospital every third month for 2 years. The treatment targets both child and parent life-style; eating habits, physical activity, sedentary activity and sleep habits. Behavior modification techniques are employed; such as self-monitoring, goal setting, reward systems, problem solving and stimulus control. In addition, FBSFT focuses on facilitating lifestyle change across different settings (family, friends, school and community) and harnessing social support for healthy habits, which is considered important for long-term weight control. The TAU condition involves an assessment day with the multidisciplinary team (pediatrician, dietician, physical therapist and psychologist) at the hospital obesity clinic. Further a session with the nurse at the hospital clinic making a plan for behavioral lifestyle changes followed by monthly follow-up sessions with their local nurse and follow-up sessions at the hospital clinic every third month for one year.

SAMPLE AND STUDY DESIGN. The sample will consist of children and adolescents (aged 6-18) referred to the Obesity Outpatient Clinic at Haukeland University Hospital. Criteria for admission to the clinic is an (IOTF) isoBMI of > 35, or a isoBMI > 30 with obesity related co-morbidity. Based on current clinic data, estimations suggest that about 60 families of children with severe obesity will be referred to the Obesity Outpatient Clinic every year and be offered treatment. Recruitment will start in February 2014 and will continue in 2015 and 2016. After consenting to participation and completion of the initial assessments the families will be randomized to either FBSFT or treatment as usual (TAU). After one year the families randomized to TAU will be offered the FBSFT treatment. Measurement points for the most important outcome measures will be pre-treatment, post-treatment (at approximately 6 months), at 12 months, 18 months and 24 months.

OUTCOME VARIABLES. Anthropometrical measures: Height, weight and waist-circumference, DXA-scans and bio-impedance measurements for determining the distribution of fat and muscle tissue. Physiological measures: Blood samples will be drawn in the morning after an overnight fast. Including measurements of total-cholesterol, HDL, LDL, TG, ASAT, ALAT, gamma-GT, bilirubin, creatinin, HbA1c and fasting insulin, c-peptide and glucose, TSH, fT4, CRP. Cortisol measurements from saliva and urine. Measurement of bloodpressure. Food records: The parents will be instructed to help their children to keep a diary of food and beverage intake for five days. They will use an electronic kitchen scale to weigh the food. Physical activity: Physical activity and sleep will be measured by using accelerometers. Psychological measures: The Child Behavior Checklist (CBCL) is a 138-item rating scale assessing behavioral and emotional symptoms in children/youth. Children's Depression Inventory (CDI). CDI is a 27-item self-report test assessing symptoms of depression in children (7-17 years). Self-Perception Profile for Children (SPPC). SPPC is a self-report measure of self-perception in children aged 8 to 14 years. The Dutch Eating Behavior Questionnaire Child version (DEBQ) is a measure of disturbed eating patterns in children and youth. The Youth Eating Disorder Examination-Questionnaire (YEDE-Q) is a self-reported measure of eating patterns and eating disorder psychopathology. OTHER MEASUREMENTS INCLUDED. The Parenting Scale (PS) is a 30-item questionnaire designed to measure different parental disciplines with children/youth. The scores on three sub-scales are calculated - Laxness, Overreactivity and Verbosity. The Barriers to Treatment Participation Scale (BTPS). The 44-item scale is developed and validated to address drop-out from treatment with out-patient psychological treatment of children and adolescents. Child and parent acceptability of the treatment will be measured by the FBSFT Acceptability Questionnaire.

STUDY AIMS:

1. To evaluate the effect of FBSFT compared to TAU for treatment of severe childhood and adolescent obesity in an ordinary health care setting on BMI, BMI SDS, body composition, cardio-metabolic health, eating habits, physical activity as well as psychological well-being.

2. To identify predictors of treatment success and treatment drop-out with a focus on family variables and mental health.

3. To evaluate treatment (FBSFT) implementation and treatment acceptability for children, parents and health care workers and experienced barriers to treatment, and how these factors influence children's and parents' treatment response.

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Family-based behavioral social facilitation therapy.

The FBSFT condition includes 17 weekly family-based treatment sessions at the hospital obesity clinic followed by monthly follow-up sessions with their local nurse and follow-up sessions at the hospital every third month for 2 years.The treatment targets both child and parent life-style; eating habits, physical activity, sedentary activity and sleep habits. Behavior modification techniques are systematically employed; such as self-monitoring, goal setting, reward systems, problem solving and stimulus control. In addition, FBSFT focuses on facilitating lifestyle change across different settings (family, friends, school and community) and harnessing social support for healthy habits, which is considered important for long-term weight control.

Group Type: EXPERIMENTAL

Family-based behavioral social facilitation therapy

Intervention Type: BEHAVIORAL

Family-based Behavioral Social Facilitation Treatment (FBSFT) is founded on the principles of standard family-based behavioural therapy for obesity. FBSFT targets life-style behaviors (diet, physical activity and sedentary activity) in a family setting. FBSFT includes some cognitive elements that are considered important in relation to behavioural change for instance problem solving and cognitive restructuring. FBSFT has an intensive treatment phase including weekly family meetings with therapists over 17 consecutive weeks. Further monthly or bi-weekly follow-up sessions with a focus on social facilitation and maintenance of healthy habits are recommended. The dietary guidance of FBSFT is based on the "Traffic light diet" in which foods are organized into GREEN, YELLOW and RED groups. Activity guidance of FBSFT uses the same system: GREEN activities have the highest intensity and should be engaged in most often, YELLOW activities sometimes, and RED activities.

Treatment as usual

The TAU condition involves an assessment day with the multidisciplinary team (pediatrician, dietician, physical therapist and psychologist) at the hospital obesity clinic. Further a session with the nurse at the hospital clinic making a plan for behavioral lifestyle changes followed by monthly follow-up sessions with their local nurse and follow-up sessions at the hospital clinic every third month for 12 months. After 12 months they will be offered treatment by family-based behavioral social facilitation therapy (as in the other treatment arm).

Group Type: ACTIVE_COMPARATOR

TAU - Treatment as usual

Intervention Type: BEHAVIORAL

This is the default treatment at the obesity clinic. After initial evaluation by paediatrician, nurse, nutritionist and physiotherapist, a "contract" is written including weight goal, nutritional plan and activity plan. Follow up monthly in primary Health care and every 3rd month at the obesity clinic.

Interventions

Family-based behavioral social facilitation therapy

Family-based Behavioral Social Facilitation Treatment (FBSFT) is founded on the principles of standard family-based behavioural therapy for obesity. FBSFT targets life-style behaviors (diet, physical activity and sedentary activity) in a family setting. FBSFT includes some cognitive elements that are considered important in relation to behavioural change for instance problem solving and cognitive restructuring. FBSFT has an intensive treatment phase including weekly family meetings with therapists over 17 consecutive weeks. Further monthly or bi-weekly follow-up sessions with a focus on social facilitation and maintenance of healthy habits are recommended. The dietary guidance of FBSFT is based on the "Traffic light diet" in which foods are organized into GREEN, YELLOW and RED groups. Activity guidance of FBSFT uses the same system: GREEN activities have the highest intensity and should be engaged in most often, YELLOW activities sometimes, and RED activities.

Intervention Type: BEHAVIORAL

TAU - Treatment as usual

This is the default treatment at the obesity clinic. After initial evaluation by paediatrician, nurse, nutritionist and physiotherapist, a "contract" is written including weight goal, nutritional plan and activity plan. Follow up monthly in primary Health care and every 3rd month at the obesity clinic.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• The sample will consist of children and adolescents (aged 6-18) referred to the Obesity Outpatient Clinic at Haukeland University Hospital by their general practitioner.
• Criteria for admission to the clinic is an (IOTF) isoBMI of > 35, or a isoBMI > 30 with obesity related co-morbidity.
• Both the child and at least one of the parents agrees to actively participate in the treatment.

Exclusion Criteria

• Severe somatic or psychiatric illness that makes adherence to the treatment program impossible.
• Somatic conditions, syndromes or medications that lead to pathological weight gain.
• Participation in other obesity treatment programs.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Petur B Juliusson

MD/PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

References

Skjakodegard HF, Danielsen YS, Morken M, Linde SF, Kolko RP, Balantekin KN, Wilfley DE, Juliusson PB. Study Protocol: A randomized controlled trial evaluating the effect of family-based behavioral treatment of childhood and adolescent obesity-The FABO-study. BMC Public Health. 2016 Oct 21;16(1):1106. doi: 10.1186/s12889-016-3755-9.

Reference Type: DERIVED

PMID: 27769209 (View on PubMed)

Other Identifiers

2013/1300/REK Vest

Identifier Type: -

Identifier Source: org_study_id